TY - JOUR
T1 - Procalcitonin-guided interventions against infections to increase early appropriate antibiotics and improve survival in the intensive care unit
T2 - a randomized trial
AU - Procalcitonin And Survival Study (PASS) Group
AU - Jensen, Jens U
AU - Hein, Lars
AU - Lundgren, Bettina
AU - Bestle, Morten H
AU - Mohr, Thomas T
AU - Andersen, Mads H
AU - Thornberg, Klaus J
AU - Løken, Jesper
AU - Steensen, Morten
AU - Fox, Zoe
AU - Tousi, Hamid
AU - Søe-Jensen, Peter
AU - Lauritsen, Anne Ø
AU - Strange, Ditte
AU - Petersen, Pernille L
AU - Reiter, Nanna
AU - Hestad, Søren
AU - Thormar, Katrin
AU - Fjeldborg, Paul
AU - Larsen, Kim M
AU - Drenck, Niels E
AU - Ostergaard, Christian
AU - Kjær, Jesper
AU - Grarup, Jesper
AU - Lundgren, Jens D
AU - Christensen, Jens Jørgen Elmer
PY - 2011/9
Y1 - 2011/9
N2 - OBJECTIVE: For patients in intensive care units, sepsis is a common and potentially deadly complication and prompt initiation of appropriate antimicrobial therapy improves prognosis. The objective of this trial was to determine whether a strategy of antimicrobial spectrum escalation, guided by daily measurements of the biomarker procalcitonin, could reduce the time to appropriate therapy, thus improving survival.DESIGN: Randomized controlled open-label trial.SETTING: Nine multidisciplinary intensive care units across Denmark.PATIENTS: A total of 1,200 critically ill patients were included after meeting the following eligibility requirements: expected intensive care unit stay of ≥ 24 hrs, nonpregnant, judged to not be harmed by blood sampling, bilirubin <40 mg/dL, and triglycerides <1000 mg/dL (not suspensive).INTERVENTIONS: : Patients were randomized either to the "standard-of-care-only arm," receiving treatment according to the current international guidelines and blinded to procalcitonin levels, or to the "procalcitonin arm," in which current guidelines were supplemented with a drug-escalation algorithm and intensified diagnostics based on daily procalcitonin measurements.MEASUREMENTS AND MAIN RESULTS: The primary end point was death from any cause at day 28; this occurred for 31.5% (190 of 604) patients in the procalcitonin arm and for 32.0% (191 of 596) patients in the standard-of-care-only arm (absolute risk reduction, 0.6%; 95% confidence interval [CI] -4.7% to 5.9%). Length of stay in the intensive care unit was increased by one day (p = .004) in the procalcitonin arm, the rate of mechanical ventilation per day in the intensive care unit increased 4.9% (95% CI, 3.0-6.7%), and the relative risk of days with estimated glomerular filtration rate <60 mL/min/1.73 m was 1.21 (95% CI, 1.15-1.27).CONCLUSIONS: Procalcitonin-guided antimicrobial escalation in the intensive care unit did not improve survival and did lead to organ-related harm and prolonged admission to the intensive care unit. The procalcitonin strategy like the one used in this trial cannot be recommended.
AB - OBJECTIVE: For patients in intensive care units, sepsis is a common and potentially deadly complication and prompt initiation of appropriate antimicrobial therapy improves prognosis. The objective of this trial was to determine whether a strategy of antimicrobial spectrum escalation, guided by daily measurements of the biomarker procalcitonin, could reduce the time to appropriate therapy, thus improving survival.DESIGN: Randomized controlled open-label trial.SETTING: Nine multidisciplinary intensive care units across Denmark.PATIENTS: A total of 1,200 critically ill patients were included after meeting the following eligibility requirements: expected intensive care unit stay of ≥ 24 hrs, nonpregnant, judged to not be harmed by blood sampling, bilirubin <40 mg/dL, and triglycerides <1000 mg/dL (not suspensive).INTERVENTIONS: : Patients were randomized either to the "standard-of-care-only arm," receiving treatment according to the current international guidelines and blinded to procalcitonin levels, or to the "procalcitonin arm," in which current guidelines were supplemented with a drug-escalation algorithm and intensified diagnostics based on daily procalcitonin measurements.MEASUREMENTS AND MAIN RESULTS: The primary end point was death from any cause at day 28; this occurred for 31.5% (190 of 604) patients in the procalcitonin arm and for 32.0% (191 of 596) patients in the standard-of-care-only arm (absolute risk reduction, 0.6%; 95% confidence interval [CI] -4.7% to 5.9%). Length of stay in the intensive care unit was increased by one day (p = .004) in the procalcitonin arm, the rate of mechanical ventilation per day in the intensive care unit increased 4.9% (95% CI, 3.0-6.7%), and the relative risk of days with estimated glomerular filtration rate <60 mL/min/1.73 m was 1.21 (95% CI, 1.15-1.27).CONCLUSIONS: Procalcitonin-guided antimicrobial escalation in the intensive care unit did not improve survival and did lead to organ-related harm and prolonged admission to the intensive care unit. The procalcitonin strategy like the one used in this trial cannot be recommended.
KW - Aged
KW - Algorithms
KW - Anti-Bacterial Agents/administration & dosage
KW - Biomarkers/blood
KW - Calcitonin/blood
KW - Calcitonin Gene-Related Peptide
KW - Female
KW - Hospital Mortality
KW - Humans
KW - Intensive Care Units
KW - Length of Stay
KW - Male
KW - Middle Aged
KW - Protein Precursors/blood
KW - Respiration, Artificial
KW - Sepsis/prevention & control
KW - Time Factors
U2 - 10.1097/CCM.0b013e31821e8791
DO - 10.1097/CCM.0b013e31821e8791
M3 - Article
C2 - 21572328
VL - 39
SP - 2048
EP - 2058
JO - Critical Care Medicine
JF - Critical Care Medicine
SN - 0090-3493
IS - 9
ER -